Careers

Careers

Mission

At Flowonix, our patient centric approach drives the design, development, and deployment of targeted drug delivery platforms whose sole purpose is to provide physicians an optimal solution for the treatment of their patients' numerous neurological disorders.

Core Values

  • Character – The common thread of our culture. One is never wrong doing what is right.
  • Integrity – Saying exactly what we mean and doing what we say.
  • Relentless – While never at the expense of progress, we push for perfection.
  • Purpose – Optimizing patient outcomes is our greater cause.

 

It's the desire to help people with life-changing technology that drives every member of the Flowonix team. At Flowonix we believe our employees are an essential component to our long-term success, and it is this mindset that drives our commitment to offer unique career opportunities.

We are passionate about having a diverse and talented workforce to solve the big problems we are seeking to tackle. We offer a competitive health and benefits package.

Browse our current job openings below. If you do not see any current openings but are interested in joining our team, please feel free to send an email to jobs@flowonix.com 

Sr. Regulatory Affairs Specialist

Position Title: Sr. Regulatory Affairs Specialist

Reports to: Director of Regulatory Affairs

Department: Regulatory Affairs

Location: Mt. Olive or Mansfield, MA

 


 

Accountability Objective: 

Responsible for the completion of assigned US and OUS Regulatory Submissions for new and existing products marketed by Flowonix Medical; assure compliance with US and OUS International regulatory requirements for Class III (US) and Active Implantable Medical Devices (EU).

Essential Functions:

  • Responsible for managing the compliance with reporting requirements related to US and OUS approvals such as MDRs, Vigilance Reporting, Post Approval Study Reports, Progress Reports and reports related to IDE and PMA approvals.
  • Responsible for the preparation of OUS regulatory submissions in order to maintain the design dossier and compliance to the essential requirements for CE marking.
  • Responsible for supporting ongoing manufacturing related to regulatory affairs, such as reviewing nonconforming material reports, engineering change notices, verification and validation protocols and reports, corrective and preventative actions and compliance with regulatory approvals and internal procedures.
  • Support regulatory involvement in the overall compliance program to meet the medical device requirements of FDA and international agencies pertaining to marketing, manufacturing, quality, and product surveillance.
  • Participate in cross functional product development teams on behalf of Regulatory Affairs and Flowonix Medical. Identify and help resolve product development issues which relate to regulatory submission activities. Coach technical activities to achieve compliance with essential requirements (e.g., design control, design validation).
  • Participate in overall document management strategies which support the device history file required by FDA regulations and product design dossier required by OUS for obtaining a design examination certificate. 
  • Support ongoing activities within other departments, carry out departmental administrative duties and other duties as assigned.

Decision Making Authority:

  • Provide guidance for internal staff on regulatory and engineering matters.
  • Assigned tasks related to US and OUS regulatory submissions to support product approvals.

Position Specifications:

  • Knowledge/Educational Requirements- Minimum of Bachelors level degree with 4 years in medical device regulatory affairs; experience with U.S. and/or E.U. submissions is required. Experience with Class III medical device submissions and/or E.U. MDD/AIMD is desirable. Experience with MDR/Vigilance reporting is desirable; excellent working knowledge of US (QSR) and OUS Quality System requirements (ISO-13485) and requirements to obtain and maintain medical device marketing approvals is required.
  • Communication/Language Skills - Must be able to effectively and persuasively communicate in English language, both verbally and in writing; must be able to read and understand scientific literature and clinical articles. Prior publication experience desirable.
  • Computer/Software Literacy - Proficient with Microsoft Office Suite of software applications, especially Word, Excel, Powerpoint and Outlook; electronic submissions require expert knowledge of Adobe Acrobat 8.0 or later. Working knowledge of Microsoft Visio, Adobe Photoshop, and other document creation tools (e.g., scanning) desirable. Must be able to conduct effective research using web-based search tools and databases.
  • Technical/Problem Solving Skills - Organized with excellent technical, analytical and problem-solving abilities; strong interpersonal skills, project management and team participation skills required.
  • Physical Demands/Work Environment - Office environment, heavy PC usage; travel required up to 25% (domestic and international).

Positions Supervised:

Direct Reports - None

Indirect Reports - Administrative Staff

Working Relationships:

Internal Contacts - Heavy cross-functional contact with all departments

External Contacts - Consultants and suppliers.

 

Please Click below to submit your resume to this position opening:

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Customer Service Representative

Position Title: Customer Service Representative

Reports to: Sr. Director, Customer Care

Department: Customer Care

Location: Mt. Olive, NJ

 


 

Accountability Objective: 

Provide excellent customer service. Process product orders accurately and on-time; maintain accurate customer records, track shipping, create and maintain inventory reports, adjust billing as required; interact with telephone, fax, email or in-person with Flowonix Medical personnel including, but not limited to, U.S. and overseas direct and distributor sales force, physician and facility customers. 

Essential Functions:

  • Provide best-in-class customer service to all customers (e.g. sales representatives, physicians, facilities, etc.)
  • Receives, verifies and processes purchase orders and/or coordinates the distribution of products to sales force or facilities. Provides information on product availability and order shipment status to orders received. Corrects the order, as necessary, and coordinates with Shipping and Receiving Clerk.
  • Identifies customer's needs and most effective method for meeting those needs.
  • Responds quickly to customer inquiries and requests.
  • Efficiently answers inbound phone calls from sales force and customers in professional manner.
  • Ability to communicate clearly in writing or verbally.
  • Process product orders timely and accurately and in accordance with established procedures.
  • manage and maintain customer records.
  • Work with Shipping and Receiving Clerk to ensure product is shipped accurately.
  • Traces customer's shipments and advises customer of order status, including tracking number.
  • Update and maintain inventory reports.
  • Provide current product inventory status when requested/required.
  • Maintain records as required by Quality Systems.
  • Other assignments as required by management.

Decision Making Authority:

Process product orders and request information as necessary to fulfill the order in a timely and accurate fashion. Analyze and interpret inventory data.

Position Specifications:

1. Knowledge/Educational Requirements:

    • Associates degree, or equivalent experience
    • 2-5 years customer service and/or inventory experience
    • Supply demand planning experience preferred

2. Skills and Abilities:

    • Excellent communication skills including verbal, written, and electronic communication.
    • Good organizational and problem solving skills.
    • Strong attention to detail, organizational and follow-up skills.
    • Good mathematical, record keeping and problem-solving skills.
    • General knowledge of finished goods distribution process and domestic/international shipping methods.
    • Proven high level of interpersonal and communication skills, including the ability to listen, resolve problems, deal with unresolved issues, delays and unexpected events.
    • Ability to work within a team as well as an individual contributor in a fast paced, changing environment.
    • Multitasks, prioritizes and meets deadlines in a timely manner.
    • Microsoft Office experience, specifically Word and Excel.
    • Ability to learn and use corporate computer systems.

3. Physical Demands/Work Environment:

    • Office-based responsibilities.

 

Positions Supervised:

Direct Reports - None

Indirect Reports - None

Working Relationships:

Internal Contacts - All personnel associated with field based activities, Customer Care, Sales, Operations, Quality and R&D personnel.

External Contacts - Consultants.

 

Please Click below to submit your resume to this position opening:

APPLY HERE